Adenocarcinoma Absent | Non-Small Cell Lung Carcinoma
Item
1. patients who were diagnosed as non-adenocarcinoma, non-small cell carcinoma of lung histologically or cytologically
boolean
C0001418 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0007131 (UMLS CUI [2])
Age
Item
2. patients must be ≥ 18 years old of age
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
3. ecog performance status ≤ 1
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
4. estimated life expectancy of more than 3 months
boolean
C0023671 (UMLS CUI [1])
Prior Chemotherapy Quantity
Item
5. treatment with only one prior chemotherapy
boolean
C1514457 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Measurable lesion Quantity CT | Measurable lesion Quantity MRI
Item
6. at least one lesion that can be measured by imaging (ct/mri) according to the response evaluation criteria in solid tumors (recist v1.1)
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0040405 (UMLS CUI [1,3])
C1513041 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0024485 (UMLS CUI [2,3])
Bone Marrow function | Absolute neutrophil count | Hemoglobin measurement
Item
7. adequate bone marrow function (absolute neutrophil count [anc] ≥ 1,500/µl, hemoglobin
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
Correction Transfusion Acceptable | Platelet Count measurement
Item
≥ 9.0 g/dl [correction by transfusion is acceptable], and platelets ≥ 100,000/µl)
boolean
C1947976 (UMLS CUI [1,1])
C0005841 (UMLS CUI [1,2])
C1879533 (UMLS CUI [1,3])
C0032181 (UMLS CUI [2])
Renal function | Creatinine measurement, serum
Item
8. adequate kidney function (serum creatinine < 1.5 x upper limit of normal [uln])
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Liver function | Serum total bilirubin measurement | Transaminase Assay
Item
9. adequate liver function (serum total bilirubin < 1.5xuln; serum transaminases levels < 2.5xunl)
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0919834 (UMLS CUI [3])
Informed Consent
Item
10. provision of fully informed consent prior to any study specific procedures
boolean
C0021430 (UMLS CUI [1])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent
Item
1. pregnant or breastfeeding women and women of childbearing potential not employing adequate contraception
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Prior Chemotherapy | Paclitaxel | docetaxel
Item
2. patients who received prior chemotherapy including paclitaxel or docetaxel
boolean
C1514457 (UMLS CUI [1])
C0144576 (UMLS CUI [2])
C0246415 (UMLS CUI [3])
Second Primary Cancer | Exception Skin carcinoma Treated | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception Curative treatment Solid Neoplasm | Exception Disease Free Duration
Item
3. patients with second primary cancer (except, adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥5 years)
boolean
C0751623 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0851140 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1273390 (UMLS CUI [4,2])
C0280100 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0012634 (UMLS CUI [5,2])
C0332296 (UMLS CUI [5,3])
C0449238 (UMLS CUI [5,4])
Defect Central Nervous System | Mental disorders | CNS metastases
Item
4. patients with defect of central nervous system (cns) or any psychiatric disorders and cns metastases
boolean
C1457869 (UMLS CUI [1,1])
C3714787 (UMLS CUI [1,2])
C0004936 (UMLS CUI [2])
C0686377 (UMLS CUI [3])
Illness Serious | Medical condition Serious | Heart Disease | Congestive heart failure Uncontrolled New York Heart Association Classification | Therapeutic procedure Unsuccessful | Coronary Artery Disease Symptomatic | Angina, Unstable | Myocardial Infarction | Abnormal cardiac conduction | Second degree atrioventricular block | Cardiac Arrhythmia Serious Requirement Pharmaceutical Preparations | Uncontrolled hypertension | Liver Cirrhosis Child-Pugh Classification | Nervous system disorder | Mental disorders | Dementia | Seizures | Communicable Disease Uncontrolled | Other medical condition Impairing Study Subject Participation Status
Item
5. other serious illness or medical conditions a. clinically significant cardiac disease (uncontrolled congestive heart disease despite treatment [nyha class iii or iv], symptomatic coronary artery disease, unstable angina or myocardial infarction, conduction abnormality like grade 2 av block, serious arrhythmia needed for medication, uncontrolled hypertension) within 6 months prior to study entry b. liver cirrhosis (≥ child-pugh class b) c. history of significant neurologic or psychiatric disorders including dementia or seizures d. active uncontrolled infection e. other serious underlying medical conditions which could impair the ability of the patient to participate in the study
boolean
C0221423 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C3843040 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0018799 (UMLS CUI [3])
C0018802 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C1275491 (UMLS CUI [4,3])
C0087111 (UMLS CUI [5,1])
C1272705 (UMLS CUI [5,2])
C1956346 (UMLS CUI [6,1])
C0231220 (UMLS CUI [6,2])
C0002965 (UMLS CUI [7])
C0027051 (UMLS CUI [8])
C0232219 (UMLS CUI [9])
C0264906 (UMLS CUI [10])
C0003811 (UMLS CUI [11,1])
C0205404 (UMLS CUI [11,2])
C1514873 (UMLS CUI [11,3])
C0013227 (UMLS CUI [11,4])
C1868885 (UMLS CUI [12])
C0023890 (UMLS CUI [13,1])
C4050412 (UMLS CUI [13,2])
C0027765 (UMLS CUI [14])
C0004936 (UMLS CUI [15])
C0497327 (UMLS CUI [16])
C0036572 (UMLS CUI [17])
C0009450 (UMLS CUI [18,1])
C0205318 (UMLS CUI [18,2])
C3843040 (UMLS CUI [19,1])
C0221099 (UMLS CUI [19,2])
C2348568 (UMLS CUI [19,3])
Investigational New Drugs | Chemotherapy | Hormone Therapy | Immunotherapy
Item
6. concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy
boolean
C0013230 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C0279025 (UMLS CUI [3])
C0021083 (UMLS CUI [4])